Aventis to produce 2.6 million more flu vaccine doses

Oct 19, 2004 (CIDRAP News) – Seeking to calm public worries about the influenza vaccine shortage, Health and Human Services (HHS) Secretary Tommy Thompson announced today that Aventis Pasteur will produce another 2.6 million doses for distribution in January.

In addition, Thompson said the nation can come up with enough antiviral drugs to treat about 40 million people, which could help compensate for the vaccine shortage. Thompson made the announcement during a teleconference this afternoon.

David Williams, chairman of Aventis Pasteur, said growth of the two influenza A strains used in the vaccine has been somewhat higher than predicted this year, making it possible to produce 2.6 million more doses. "We're very fortunate that we ended up with enough concentrate of the two A strains to provide the 2.6 million doses we're talking about," he said.

When the extra doses are ready in January, they will bring the company's total production this year to 58 million doses, Williams said.

Thompson said that with the Aventis supply and another 2 million doses of FluMist, the nasal spray vaccine licensed only for healthy people aged 5 to 49 years, the nation has a total of 60 million doses of vaccine for this season.

HHS had hoped for about 100 million doses, but 46 million to 48 million doses of Chiron vaccine evaporated 2 weeks ago when British regulators determined that signs of contamination in some lots made the entire supply unsafe. US officials concurred last week after inspecting Chiron's plant in Liverpool, England.

Thompson said the nation has an "ample supply" of antiviral medications to help cope with the flu season. "We've gone out and stockpiled antiviral medications for more than 7 million people," he said. In a news release, HHS said it has spent $87.1 million to stockpile 2.3 million doses of oseltamivir (Tamiflu) and $34 million to buy rimantadine capsules to treat 4.25 million adults and rimantadine syrup for 750,000 children.

Additional supplies of antivirals, including zanamivir and amantadine, are in private hands, and more could be produced this season, Thompson added. "All told, between existing stockpiles and private supplies and production capabilities, FDA [the Food and Drug Administration] estimated there could be enough to treat nearly 40 million people through the flu season," he said.

Thompson said the FDA is negotiating with Canada for some possible additional vaccine doses. Previous reports have said a Canadian company called ID Biomedical could potentially supply about 1.5 million doses.

Acting FDA Commissioner Lester Crawford said the agency is continuing to look "throughout the world" for vaccine, but any available doses may not be licensed in the United States. "It may be that we can license some of these vaccines under investigational new drug applications for a limited amount of time," he said. "But it's not possible at this time to say how many additional doses we'll find and what the fate of them will be in the regulatory process."

Health officials have asked healthy people to forgo flu shots this years so that people in high-risk groups—infants, the elderly, people with certain chronic medical conditions, and healthcare workers caring for people at high risk—can be vaccinated. Thompson stressed the message again today: "Please, if you are not in a priority category, do not get this shot." He also urged healthcare workers not to vaccinate people who don't need it.

About 24 million doses of vaccine remain, and the Centers for Disease Control and Prevention will be working with Aventis to distribute them over the next several weeks, Thompson said. "We need all of us to take a deep breath," he said. "We've worked through vaccine supply problems in the past and we can do so now as well." He urged elderly people not to stand in long lines for vaccine, but to be patient and persistent in seeking it.

Thompson today vigorously defended the Bush administration's record on flu preparedness. Sen. John Kerry, Bush's Democratic opponent in the Nov 2 election, has criticized him over the vaccine shortage.

Thompson said Bush has increased spending on flu vaccine by 700%, from about $40 million in 2001 to $284 million in 2005. He said HHS has asked for $100 million to develop cell-culture technology to produce flu vaccine and improve conventional egg-based production of flu vaccine. The administration also created the first federal flu vaccine stockpile, consisting of 4.5 million doses for the Vaccines for Children program, he added.

The HHS secretary also announced "the formalization of a federal task force that will coordinate our nation's efforts to ensure that the flu vaccine and treatment medication goes to those who need it most and without any price gouging."

Thompson dismissed the suggestion from a Democratic senator that he declare a pubic health emergency over the flu vaccine shortage. "The public health emergency would just create more confusion and not accomplish anything," he said.

He also talked about reasons for the decline in the number of US flu vaccine manufacturers from five in 1994 to two today. He cited "high risk associated with a complex production process, unpredictable consumer demand that often leaves manufacturers with millions of unsold doses," and "costly liability lawsuits."

See also:

Oct 19 HHS news release on supply of flu vaccine and antiviral drugs
http://archive.hhs.gov/news/press/2004pres/20041019a.html

Oct 18 CDC guidelines on use of use of antiviral drugs for prevention and treatment of flu
http://www.cdc.gov/flu/professionals/treatment/0405antiviralguide.htm

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